Adaptor for coupling to a medical container

ABSTRACT

An adaptor for coupling with a medical container, including: a tubular body receiving a pierceable elastomeric piece, defining an inner cavity of the adaptor, the pierceable elastomeric piece being movable within the tubular body between a first position, in which a distal part of the pierceable elastomeric piece forms a seal of the cavity, and a second position, proximally spaced from the first position, in which the distal part opens the seal of the cavity, an air inlet, a filtering system for filling the inner cavity with decontaminated air, and a gripping member for securing the adaptor to the medical container. Also, an assembly comprising such an adaptor and a medical container.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is the United States national phase of InternationalApplication No. PCT/SG2013/000043 filed Feb. 1, 2013, and claimspriority to Singapore Patent Application No. 201200772-0 filed Feb. 2,2012, the disclosures of which are hereby incorporated in their entiretyby reference.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to an adaptor for coupling to a medicalcontainer such as a vial containing a pharmaceutical product, such as avaccine, said adaptor allowing for multiple aseptic needle piercingswith an injection device to be filled with part of the product containedin the medical container.

Description of Related Art

In this application, the distal end of a component or apparatus must beunderstood as meaning the end furthest from the hand of the user and theproximal end must be understood as meaning the end closest to the handof the user, with reference to the injection device intended to be usedwith said component or apparatus. As such, in this application, thedistal direction must be understood as the direction of injection withreference to the injection device, and the proximal direction is theopposite direction, i.e. the direction of the transfer of the productfrom the vial to the injection device.

One of the ways to improve health is to immunize entire populationsagainst a number of diseases. To date, injection administration is themost common method of administering vaccines.

Each year, numerous drugs, for example vaccines, need to be preparedthroughout the world by healthcare institutions. Many vaccinecompositions are usually not stable at room temperatures and they mustbe stored at rather specific cold temperatures. Indeed, due to theirbiological nature, vaccines are complex to handle and to store. Vaccinesare usually temperature sensitive and typically need to be maintainedand stored at all time between 2 and 8 degrees Celsius (° C.). Somevaccines will be more sensitive to heat exposure and others will besensitive to freezing. Therefore, maintaining and monitoring theappropriate temperatures during the storage and the handling of vaccinesis a critical issue in order to sustain their efficacy. Overexposure toheat as well as overcooling may result in the destruction of thebiological elements of the vaccines. Use of vaccines not stored inappropriate conditions may lead to not effective vaccination of thepopulations against diseases and may lead to expensive campaigns withlimited results.

Furthermore, it is critical that the cold chain be not interrupted fromproduction of the drug at a pharmaceutical company to its administrationto the patient.

From a supply chain perspective, the most efficient vaccine packaging isthe multidose container, such as a multidose vial, that is to say, avial that may contain up to 10, 100 or 1000 doses of vaccine, one dosebeing intended for one patient. These vials are usually closed by aseptum. In preparation of an injection of a vaccine, the user piercesthe septum of the medical container with the needle of an empty syringe,he then fills the syringe with one dose of vaccine and proceeds to theinjection of the vaccine to the patient.

As such, multidose vials imply that the septum of the vial be piercedsuccessively a high number of times, namely as many as the number ofdoses present in the vial. In order to ensure safe injections, thesterility of the septum of the vial should be maintained during thewhole time the vial is used.

Anyway, in locations where it is difficult to maintain favorablehygienic conditions such as remote locations which are far from townsand from hospital facilities, the multidose vials may be handled andmanipulated at ambiant air. In such cases, the septum of the vial may becontaminated either by the ambiant air, or, each time a dose of vaccineis removed, by the needle of the empty syringe used.

In addition, in regions where there is limited or potentially no supplyof energy to power cooling equipment such as a refrigerator, themultidose vials may be maintained in cold conditions by simple contactwith ice packs. As time goes by, part of the ice may melt and turn intowater, and the septum of the multidose vials may be in contact with suchwater that may contaminate the septum of the vial.

It may then happen that a multidose medical container, such as forexample a 10-dose medical container, is opened and that only three dosesare used, for vaccinating three patients only, the remaining content ofthe medical container being wasted because not intended to beadministered in a sufficiently short time after opening of the medicalcontainer in order to guaranty the vaccine or drug sterility.

Vaccination campaigns can therefore be made difficult in some regionsand a significant proportion of vaccines may be wasted by the time theyreach their target. This has an unacceptable cost to the healthorganizations in charge of immunization campaigns. In addition, it mayhappen that in case of vaccination campaigns, or pandemic, hundreds ofpatients need to be vaccinated in a very short time, in locations whereit is difficult to maintain favorable hygienic conditions such aslocations which are far from towns and from hospital facilities.

Therefore, it would be desirable to provide a device that would allowseveral successive safe piercings of a multidose vial septum and thatwould guarantee that said piercing be carried out in aseptic conditions.In particular it would be desirable to provide a device that wouldguarantee that the septum be made sterile at the time of injection act,or be maintained sterile during the lifetime of the multidose vial, andthat would prevent wastage of the drug, even if the multidose vial isnot stored in aseptic conditions.

SUMMARY OF THE INVENTION

A first aspect of the present invention is an adaptor for coupling witha medical container having a collar closed by a septum, said septumhaving an outer surface directed towards the outside of the medicalcontainer, the adaptor comprising:

-   -   a tubular body substantially closed at its distal end with a        transversal wall provided with a central hole and substantially        closed at its proximal end by a pierceable elastomeric piece,        said pierceable elastomeric piece, transversal wall and tubular        body together defining an inner cavity of said adaptor, said        pierceable elastomeric piece being movable within said tubular        body between a first position, in which a distal part of said        pierceable elastomeric piece forms a seal of said central hole,        and a second position, proximally spaced from said first        position, in which said distal part opens the seal of said        central hole,    -   an air inlet for allowing air from the outside to enter said        inner cavity at least when said pierceable elastomeric piece        moves from its first position to its second position, said air        inlet comprising a filtering system for decontaminating said        entering air before it reaches said inner cavity, and    -   a gripping member for securing the adaptor to the medical        container so that the distal surface of said transversal wall is        brought in contact with the outer surface of said septum when        said adaptor is secured on said medical container.

The adaptor of the invention is intended to be mounted on a medicalcontainer, for example a conventional vial, for storing pharmaceuticalproducts, such as multidose vials for vaccines. Such a vial 1 is shownon FIGS. 1A-1C and generally comprises a tubular barrel 2 having alongitudinal axis A, closed at an end and having a collar 3 at theopposite end, said collar 3 being closed by a septum 4. Usually, theseptum 4 is fixedly attached to the collar 3 of the vial 1 by aperipheral band 5, said peripheral band 5 leaving a part of the septum4, herein called outer surface 4 a of the septum, directly facing theoutside of the vial 1, namely the outside environment. The septum 4 isusually made of a material impermeable to gas and liquid and it sealshermetically the content of the vial 1. The septum 4 is also pierceableby the needle of an injection device intended to be filled with theproduct contained in the vial, said septum 4 being accessible to saidneedle via its outer surface 4 a.

In the present application, “pierceable” means that the septum or theelastomeric piece of the adaptor may be pierced and traversed by theneedle of an injection device such as a syringe, an auto-injector or areconstitution device, for example for administering a pharmaceuticalproduct such as a drug or vaccine.

The gripping member of the adaptor of the invention may be any membercapable of securing the adaptor around the medical container, and inparticular around the collar of the medical container, either in atemporary or permanent way.

The adaptor of the invention allows piercing the septum of the medicalcontainer in favorable hygienic conditions multiple successive times,and enables the decontamination of outside air likely to enter themedical container. The adaptor is provided to the user with thepierceable elastomeric piece in its first position. Indeed, when theuser decides to fill an empty injection device with a dose of drugcontained in the medical container, he simply secures the adaptor on themedical container by means of the gripping member, thereby bringing incontact the distal surface of the transversal wall of the adaptor andthe outer surface of the septum. After the adaptor has just been securedon the medical container, the pierceable elastomeric piece is still inits first position, and the distal part of the pierceable elastomericpiece sealing the central hole of the transversal wall of the adaptor isin tight contact with the outer surface of the septum of the medicalcontainer. The user then causes the pierceable elastomeric piece totransition from its first position to its second position. During thisstep, the outer surface of the septum replaces the distal part of thepierceable elastomeric piece in its function of sealing the centralhole. As a consequence, when the pierceable elastomeric piece moves fromits first position to its second position, a vacuum is created in theinner cavity and air from the outside automatically enters via the airinlet. The air inlet is preferably distinct from said central hole. Theair from the outside is caused to travel through the filtering system ofthe air inlet. As a consequence, when the air from the outside reachesthe inner cavity, said air is decontaminated. The result is the presenceof a cavity filled with decontaminated air, located between thepierceable elastomeric piece of the adaptor and the outer surface of theseptum of the medical container. As a consequence, introducing theneedle in the medical container implies that the needle pierces andtraverses the elastomeric piece of the adaptor in the first place.During this step, the needle mechanically rubs against the materialforming the elastomeric piece and it is naturally cleaned, as thepotential bacteria are wiped out from the needle when said needlepenetrates the elastomeric piece. In addition, once the needle protrudesout of the elastomeric piece of the adaptor, it enters the inner cavityof the adaptor, which is filled with decontaminated air. The needle istherefore not contaminated and it can further enter the septum of themedical container with no risk to be contaminated by any foreignelements.

The user may repeat the piercing step with the needle of a new emptyinjection device until all the doses contained in the medical containerare removed. Indeed, each time a dose of product is removed from themedical container, the vacuum thereby created in the medical containeris transferred to the inner cavity via the hole generated in the septumby the needle. The inner cavity consequently sucks additional air fromthe outside. Since this additional air needs to travel through thefiltering system of the air inlet before reaching the inner cavity, thisinner cavity remains filled with decontaminated air during the wholeprocess of removing successively several doses of product from themedical container. By preventing all direct contamination via a needleand all indirect contamination from the outside environment, the adaptorof the invention acts as a protection of the septum and of the productstored into the medical container.

In embodiments, the pierceable elastomeric piece is made of a gas andliquid impermeable material capable of flexing under pressure. Thepierceable elastomeric piece may show an average thickness ranging fromabout 0.5 to about 5 mm, preferably from about 1 to about 3 mm. Thepierceable elastomeric piece may show a hardness ranging from about 10to about 100 Shore A, preferably from about 40 to about 70 Shore A,measured according to standard DIN 53505.

Suitable materials for the pierceable elastomeric piece of the adaptorof the invention include natural rubber, acrylate-butadiene rubber,cis-polybutadiene, chloro or bromobutyl rubber, chlorinated polyethyleneelastomers, polyalkylene oxide polymers, ethylene vinyl acetate,fluorosilicone rubbers, hexafluoropropylene-vinylidenefluoride-tetrafluoroethyleneterpolymers, butyl rubbers, polyisobutene,synthetic polyisoprene rubber, silicone rubbers, styrene-butadienerubbers, tetrafluoroethylene propylene copolymers,thermoplastic-copolyesters, thermoplastic elastomers, or the like or acombination thereof.

In embodiments, the pierceable elastomeric piece is self-resealing. By“self-resealing” it is meant that the elastomeric piece closes again thehole produced by the piercing of the needle, automatically and rapidly,for example in less than 0.5 seconds, once the needle is removed fromthe elastomeric piece. This automatic closure step may occur a highnumber of times, in particular as many times as necessary for removingthe numerous doses of products present in the multidose medicalcontainer. Suitable materials for self-resealing pierceable elastomericpiece of the adaptor of the invention include synthetic polyisoprene,natural rubber, silicone rubber, thermoplastic elastomers, or the likeor a combination thereof.

In embodiments, the adaptor further comprises a pulling member, safelyattached to said pierceable elastomeric piece, for allowing a user tomanually move said pierceable elastomeric piece from its first positionto its second position. Because the pierceable elastomeric piecesubstantially closes the proximal end of the tubular body of theadaptor, it is in tight contact against the inner wall of the tubularbody and its movement within the tubular body may need significantforce. The presence of a pulling member, for example made of a rigidmaterial, safely attached to the pierceable elastomeric piece, and thatthe user may firmly grasp in his hands, assists the user and makes iteasier for him to pull proximally on the pierceable elastomeric piece soas to move it from its first position to its second position.

In embodiments, the adaptor further comprises a locking system formaintaining said pierceable elastomeric piece in its second position.Such a locking system ensures that the pierceable elastomeric pieceremains in the adequate position for proceeding safely and in favorablehygienic conditions to the successive removals of doses of product.Moreover, once the adaptor is secured on the medical container, theadaptor constitutes a protection against misuse.

In embodiments, the adaptor comprises a blister surrounding said adaptorin a storage state. In particular, the blister may be made of a rigidshell closed by a pellicle film. Such a blister preserves the sterilityof the adaptor prior use and protects it during shipping and storage.

In embodiments, the blister may be removable by proximal force exertedon the blister, and the blister comprises a coupling surface forreleasably coupling the blister to the pierceable elastomeric pieceduring the step of removal of the blister, removal of said blisterthereby causing the pierceable elastomeric piece to transition from itsfirst position to its second position. In particular, when the pullingmember is present, the blister comprises a coupling surface abuttingagainst a distal face of an outer radial rim of said pulling member whenthe blister surrounds the adaptor in the storage state of the adaptor.As such, when the user removes the blister by pulling it in the proximaldirection, the coupling surface pushes the outer radial rim of thepulling member in the proximal direction. Since the pulling member issafely attached to the pierceable elastomeric piece, this pierceableelastomeric piece is moved in the proximal direction and reaches itssecond position. The coupling surface of the blister then becomesdisengaged from the outer radial rim of the pulling member and theblister is fully removed from the adaptor. The adaptor is therefore easyto use with no other movement required from the user than securing theadaptor on the medical container and removing the blister. Moreover, theblister limits the contamination of the adaptor by the user as no directcontact is required between the adaptor and the user's hands.

In embodiments, the gripping member may be a lateral clipping membercapable of being laterally mounted on the collar of said medicalcontainer. The lateral clipping member may comprise a U-shaped elementintended to be engaged on said collar via the open part of the U-shapedelement, the curved part of the U-shaped element partially surroundingthe collar, said U-shaped element extending from said transversal wallin the distal direction. For example, the transversal wall may jointogether the two branches of the U of the U-shaped element.

In other embodiments, the gripping member is an axial clipping membercapable of being axially mounted on the collar of said medicalcontainer. For example, the axial clipping member may comprise a skirtcapable of being axially engaged on said collar, said skirt extendingfrom said transversal wall in the distal direction.

In embodiments, the adaptor further comprises a cleaning pad, saidcleaning pad-being configured to at least partially slide on said outersurface of said septum when the adaptor is being mounted on the medicalcontainer. Such embodiments allow the outer surface of the septum, wherethe distal tip of the needle is intended to penetrate, to beautomatically cleaned before the adaptor is secured to the medicalcontainer.

The cleaning pad may be any pad, such as fabric or sponge, for exampleout of cotton or any other porous material, and may be treated by acleaning solution. For example, the cleaning pad may comprise adisinfecting agent. In this case, the outer surface of the septum isdisinfected before the pierceable elastomeric piece of the adaptor comesin contact with it. The disinfecting agents may be selected fromalcohols, such as ethanol or isopropanol, organic solvents, such asnitrofurane, toluene, phenol and derivatives thereof, derivatives ofquinoline and acridine, salts such as sodium hypochlorite, sodiumchlorite or sodium chlorate, chlorine dioxide, salts of iodine, mercury,silver, ammonium, or the like or a combination thereof. For example, thedisinfecting agent may be selected according to the most common bacteriaand viruses that may be found in the area of use of the medicalcontainer.

In particular, the cleaning pad is provided as a part of the adaptor,for example as a projection extending outwardly from the transversalwall. The user has no additional operation or action to do than simplymounting the adaptor on the medical container. Because of the locationand configuration of the cleaning pad on the adaptor, the cleaning padautomatically slides on the outer surface of the septum, thereby wipingout potential bacteria or contamination agents present on said outersurface, when the user completes the step of mounting the adaptor on thecollar of the medical container.

For example, in embodiments where the lateral clipping member comprisesa U-shaped element intended to be engaged on said collar via the openpart of the U, the curved part of the U partially surrounding thecollar, the transversal wall may be provided with a projection extendingradially in the direction of the free ends of the U, a distal face ofsaid projection being provided with said cleaning pad. As such, when theuser approaches the free ends of the U of the lateral clipping membertowards the collar of the medical container, the cleaning pad enters incontact with an edge of the outer surface of the septum. While the usercontinues to move the lateral clipping member towards the collar so asto mount it thereon, the cleaning pad slides on the outer surface of theseptum, until it loses contact with said septum when the lateralclipping member reaches its position where it is secured on the collar.In this position, because of its location at the free ends of the U, thecleaning pad does not face the septum anymore and it does not preventthe piercing of the septum by the needle. During the mounting step ofthe adaptor on the collar as described above, the sliding of thecleaning pad onto the outer surface of the septum wipes out the bacteriaand/or contamination elements potentially present on said outer surface.The outer surface of the septum is therefore decontaminated when theelastomeric piece of the adaptor comes in contact with it.

In embodiments where the axial clipping member comprises a skirt capableof being axially engaged on said collar, the cleaning pad may be abreakable membrane attached to the inner wall of the skirt. As such,when the user approaches the distal free end of the skirt towards thecollar of the medical container, the breakable membrane enters incontact with the outer surface of the septum. While the user continuesto move the axial clipping member distally so as to mount it on thecollar of the medical container, the breakable membrane, which isattached to the inner wall of the skirt, becomes stretched out on theouter surface of the septum and finally breaks on said outer surface andis torn in several parts that slide on said outer surface while theaxial clipping member reaches its position where it is secured on thecollar. In this position, because it is now torn in several partshanging down from the inner walls of the skirt, the membrane does notface the septum anymore and it does not prevent the piercing of theseptum by the needle to take place. During the mounting step of theadaptor on the collar as described above, the sliding of the severaltorn parts of the breakable membrane on the outer surface of the septumhas wiped out the bacteria and/or contamination elements potentiallypresent on said outer surface. The outer surface of the septum istherefore decontaminated when the elastomeric piece of the adaptor comesin contact with it.

In embodiments, the cleaning pad is located on a removable part of saidadaptor. For example, said removable part may be removed from saidadaptor once said adaptor is secured on said medical container. Such acleaning pad may be used for additional cleaning by the users of themedical container, the septum and/or other surfaces of the injectiondevice, or even for the cleaning of the patient's skin.

Alternatively, the cleaning pad may be provided on the blister. Inembodiments, the removable part on which the cleaning pad is located isa portion of a blister surrounding said adaptor in a storage state. Forexample, the portion of said blister may remain on the adaptor while theadaptor is mounted on the collar and may be removed thereafter, once thecleaning pad has completed its function of decontaminating the outersurface of the septum.

In embodiments, the adaptor further comprises a pierceabledecontamination insert located proximally with respect to saidpierceable elastomeric piece. In such embodiments, the distal tip of theneedle therefore first pierces the decontamination insert, in which itis decontaminated, then the pierceable elastomeric piece, in which it issubmitted to a mechanical cleaning as explained above, before enteringin contact with the outer surface of the septum of the vial. Forexample, the pierceable decontamination insert may be a sterilizing gel.

In embodiments, the inner wall of the inner cavity may be coated with ananti-condensation coating. The temperature changes induced by moving themedical container from a refrigerated storage area to externalenvironment may yield condensation, especially in humid areas. Suchcondensation, which may lead to an environment suitable for bacteriadevelopment on the surface of the inner cavity can thus be avoided.Therefore, the coating acts as a supplemental decontamination system ifsome contaminants reach the inner cavity.

Another aspect of the invention is an assembly comprising a medicalcontainer having a collar closed by a septum, said septum having anouter surface directed towards the outside of the medical container, andan adaptor as described above.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C are respectively a perspective view, a partial side view anda partial cross section view of a conventional vial on which the adaptorof the invention is to be mounted,

FIG. 2A is a cross section view of an adaptor of the invention in thestorage state,

FIG. 2B is a cross section view of the adaptor of FIG. 2A just afterhaving been mounted on a vial,

FIGS. 3A-D are respectively a perspective view from the top, aperspective view from the bottom, a side view and a cross section viewof the tubular body of the adaptor of FIG. 2A,

FIGS. 4A-4C are respectively a perspective view from the top, aperspective view from the bottom, and a side view of the pulling memberof the adaptor of FIG. 2A,

FIGS. 5A-5C are respectively a perspective view from the top, aperspective view from the bottom, and a cross section view of thepierceable elastomeric piece of the adaptor of FIG. 2A,

FIG. 6A is a cross section view of the adaptor of FIG. 2A once securedon the vial, with the pierceable elastomeric piece in its secondposition, and ready to be used in connection with an injection device;FIG. 6B is a partial view of FIG. 6A at a larger scale,

FIG. 7 is a cross section view of an alternative embodiment of theadaptor of the invention,

FIG. 8 is a cross section view of an alternative embodiment of theadaptor of the invention,

FIG. 9 is a cross section view of an alternative embodiment of theadaptor of the invention,

FIG. 10 is a cross section view of an alternative embodiment of theadaptor of the invention,

FIG. 11 is a cross section view of an alternative embodiment of theadaptor of the invention,

FIGS. 12A and 12B are partial cross section views of an alternativeembodiment of the adaptor of the invention, provided with a breakablemembrane, respectively in the storage position, and once the adaptor hasbeen secured on the vial.

DESCRIPTION OF THE INVENTION

With reference to FIG. 2A is shown an adaptor 10 of the invention, in astorage position. The adaptor 10 is intended to be mounted on a medicalcontainer such as the multidose vial 1 as shown on FIGS. 1A-1C.

The adaptor 10 of FIGS. 2A-5C comprises a tubular body 20 receiving apierceable elastomeric piece 30 and a pulling member 40.

With reference to FIGS. 3A-3D, the tubular body 20 will now be describedin detail. The tubular body 20 comprises a tubular element 21 open atits proximal end 21 a and substantially closed at its distal end 21 b bya transversal wall 22 provided with a central hole 23. The tubularelement 21 is provided at its proximal end 21 a with two longitudinalwindows 24 diametrically opposed. Each window 24 is provided on itslateral walls with two inner pegs 24 a facing each other and therebyforming a narrowing 24 b of the window 24. Each window 24 is furtherprovided with two proximal pegs 24 c facing each other, the inner pegs24 a and the proximal pegs 24 c forming altogether a recess 24 e.

At the distal end 21 b of the tubular element 21, the transversal wall22 extends radially outwardly beyond the tubular element 21 and isprovided with a distal tubular wall 25 so as to form a skirt 26. As willbe seen from the description below, the skirt 26 is intended to be usedas the gripping member for securing the adaptor 10 on the collar 3 ofthe vial of FIGS. 1A-C. As such, the skirt 26 is dimensioned and shapedso as to be capable of surrounding the collar 3 of the vial 1 of FIGS.1A-1C. The distal tubular wall 25 is provided with four distal slots 25a defining four radially outwardly deflecting legs 25 b for the distaltubular wall 25. Two opposite deflecting legs 25 b are each providedwith a longitudinal window 27 a and with an inner radial stop 27 b. Thetwo other opposite deflecting legs 25 b are each provided with acircumferential window 28 a and with an outer radial stop 28 b.

With reference to FIGS. 4A-4C, the pulling member 40 will now bedescribed in detail. The pulling member 40 comprises a proximal tubularportion 41 and a distal tubular portion 42, the proximal tubular portion41 having an outer diameter greater than the outer diameter of thedistal tubular portion 42, the proximal and distal tubular portions (41,42) being linked to each other by an intermediate tubular portion 43 ofouter diameter less than the outer diameters of both the proximal anddistal tubular portions (41, 42). The intermediate tubular portion 43therefore forms an annular recess 44 of the pulling member 40.

The outer wall of the proximal tubular portion 41 is provided with twodiametrically opposed radial projections 45, the function of which willbe explained further below.

As will appear from the description below, the pulling member 40 isdimensioned and shaped so as to be partially received within thepierceable elastomeric piece 30 (FIGS. 5A-5C).

The pulling member 40 is for example made of a rigid material, such aspolypropylene, polystyrene, polycarbonate, acrylonitrile butadienestyrene, high-density polyethylene, or the like or a combinationthereof.

With reference to FIGS. 5A-5C, the pierceable elastomeric piece 30 willnow be described in detail.

The pierceable elastomeric piece 30 comprises a proximal ring 31defining a central recess 38 closed at its distal end by a transversalwall 32. From the central region of the distal face of the transversalwall 32 extends a cylindrical projection 33 ending with a distal plug 34having an outer diameter greater than that of the cylindrical projection33. The proximal ring 31 is provided at its proximal end with an innerannular rim 35 forming an inner abutment surface 35 a in the proximaldirection.

The outer surface of the proximal ring 31 is provided with a pluralityof interrupted circumferential ridges 36. As will be seen from thedescription below in connection with FIG. 6B, this plurality ofinterrupted circumferential ridges 36 define a labyrinthic path 37 forair to circulate from a proximal end 31 a to a distal end 31 b of theproximal ring 31 when the pierceable elastomeric piece 30 is receivedwithin the tubular body 20 of the adaptor 10.

The elastomeric piece 30 is made of a material impermeable to gas andliquid and capable of flexing under pressure. The pierceable elastomericpiece may show an average thickness ranging from about 0.5 to about 5mm, preferably from about 1 to about 3 mm. The pierceable elastomericpiece may show a hardness ranging from about 10 to about 100 Shore A,preferably from about 40 to about 70 Shore A, measured according tostandard DIN 53505.

Suitable materials for the pierceable elastomeric piece of the adaptorof the invention may include natural rubber, acrylate-butadiene rubber,cis-polybutadiene, chloro or bromobutyl rubber, chlorinated polyethyleneelastomers, polyalkylene oxide polymers, ethylene vinyl acetate,fluorosilicone rubbers, hexafluoropropylene-vinylidenefluoride-tetrafluoroethyleneterpolymers, butyl rubbers, polyisobutene,synthetic polyisoprene rubber, silicone rubbers, styrene-butadienerubbers, tetrafluoroethylene propylene copolymers,thermoplastic-copolyesters, thermoplastic elastomers or the like or acombination thereof.

Preferably, the elastomeric piece is self-resealing and it automaticallyseals the hole produced by the piercing of the needle, automatically andrapidly, for example in less than 0.5 seconds, once the needle isremoved from the elastomeric piece. This automatic closure step mayoccur a high number of times, in particular as many times as necessaryfor removing the numerous doses of products present in the multidosevial 1. Suitable materials for self-resealing pierceable elastomericpiece of the adaptor of the invention may include syntheticpolyisoprene, natural rubber, silicone rubber, thermoplastic elastomers,or the like or a combination thereof.

In embodiments, the pierceable elastomeric piece may further comprise amaterial including antiseptic agents, such as silver ions or copperions. For example, silver salt or copper salt may be covalently linkedto the polymer matrix of material comprised in the pierceableelastomeric piece. Alternatively, silver salts or copper salts may beincluded as a load during the manufacturing of the polymer comprised inthe pierceable elastomeric piece. For example, the polymer matrix may beselected from silicone rubber, butyl rubber and/or halogenobutyl rubber.

In embodiments, the pierceable elastomeric piece is made of a materialcomprising a silicone rubber including silver ions: such products arecommercially available from the company Momentive Performance Materialsunder the tradename “Statsil®” or “Addisil®”. In other embodiments, thepierceable elastomeric piece consists in a material including silverions, such as silicone rubber including silver ions. In otherembodiments, the pierceable elastomeric piece may consist in a materialincluding copper ions.

Pierceable elastomeric pieces of the adaptor of the invention,comprising a material including antiseptic agents, such as silver ionsor copper ions, show antiseptic properties. The growth of bacteria atthe surface of the pierceable elastomeric piece is therefore directlyprevented. These materials also show hydrophobic properties whichprevent condensation formation, thereby further reducing growth ofbacteria. As a consequence, when a needle pierces a pierceableelastomeric piece including such antiseptic agents, in view of enteringa vial for removing a dose of product from said vial, the risk ofcontamination of the vial content is reduced.

Alternatively or in combination, the pierceable elastomeric piece maycomprise a coating comprising an antiseptic agent, such as chlorhexidinedi-acetate. For example, the pierceable elastomeric piece may comprise abutyl rubber or a halogenobutyl rubber coated with a coating comprisingchlorhexidine di-acetate. Such a coating may be obtained by UVcross-linking. The antiseptic action of such a coating may occur withinminutes and such a coating may therefore be able to clean a contaminatedneedle during its insertion within the pierceable elastomeric piece.

The use of adaptor 10 of FIG. 2A with a vial of FIGS. 1A-C will now beexplained with reference to FIGS. 1A-6B.

With reference to FIG. 2A, the adaptor 10 is in a storage position andit is packaged in a blister 50 surrounding it completely. In the exampleshown, the blister 50 comprises a rigid shell 51 surrounding the adaptorexcept for the distal open end of the skirt 26, which is closed by atearable pellicle film 52.

In this storage position, the pierceable elastomeric piece 30 isreceived within the tubular element 21, the outer surface of theproximal ring 31 being in tight contact with the inner wall of thetubular element 21. The proximal ring 31 therefore substantially closesthe proximal end 21 a of the tubular element 21. Nevertheless, becauseof the presence on the outer surface of the proximal ring 31 of theplurality of interrupted circumferential ridges 36 defining alabyrinthic path 37 as explained above, air from the outside will beable to circulate from a proximal end 31 a of the proximal ring 31 toits distal end 31 b, once the blister 50 or the pellicle film 52 isremoved, as will be described below. In this position also, thepierceable elastomeric piece is in a first position, in which the distalplug 34 of the pierceable elastomeric piece 30 seals the central hole 23of the transversal wall 22.

The pierceable elastomeric piece 30, the transversal wall 22 and theinner wall of the tubular body 20 therefore define together an innercavity 60 of the adaptor 10. As seen above, the labyrinthic path 37present on the outer surface of the proximal ring 31 of the pierceableelastomeric piece 30 ends at the distal end 31 b of the proximal ring 31which is directly connected to the inner cavity 60.

As shown in FIG. 2A, the pulling member 40 is safely attached to thepierceable elastomeric piece 30. Indeed, the distal tubular portion 42is received in the central recess 38 of the proximal ring 31 and theinner annular rim 35 is engaged in the annular recess 44 of the pullingmember 40.

In this storage position and first position of the pierceableelastomeric piece 30, the radial projections 45 of the pulling memberare engaged in the distal region of the windows 24 of the tubularelement 21, as shown on FIG. 2A.

In addition, as shown in FIG. 2A, the outer surface of proximal tubularportion 41 of the pulling member 40 is not in tight contact with theinner wall of the tubular element 21. As a consequence, a tubular space70 is present between the outer surface of proximal tubular portion 41of the pulling member 40 and the inner wall of the tubular element 21.This tubular space 70 is in connection, at its distal end with thelabyrinthic path 37 present on the outer surface of the proximal ring 31and which ends directly in the inner cavity 60, and, at its proximal endwith the window 24, and consequently with the outside air once theblister 50 and pellicle film 52 are removed from the adaptor. The window24, the tubular space 70 and the labyrinthic path 37 form altogether anair inlet 80 for entry of air from the outside, once the blister 50 andpellicle film 52 are removed, towards the inner cavity 60.

Once the user is ready to proceed to the withdrawal of a dose of productcontained in the vial 1, he removes the pellicle film 52 in order toopen the blister 50. In the embodiment shown on FIG. 2B, the shell 51remains on the adaptor 10 until the adaptor 10 is secured on the collar3 of the vial 1, and it is removed thereafter. In other embodiments, thewhole blister 50 may be removed before mounting the adaptor 10 on thevial 1.

With the shell 51 still present around the adaptor 10, the user movesthe distal free end of the skirt 26 of the tubular body 20 towards thecollar 3 of the vial 1, and he mounts the adaptor 10 on the collar 3 byaxial clipping of the skirt 26 on the collar 3 of the vial 1, as shownin FIG. 2B. As shown in this Figure, the distal surface of thetransversal wall 22 is now in contact with the outer surface 4 a of theseptum 4. In particular, the distal plug 34 of the pierceableelastomeric piece 30 is pressed against the outer surface 4 a of theseptum 4 of the vial 1. In addition, because of the pegs 27 b areengaged in the collar 3 of the vial 1, the adaptor 10 is firmly securedonto the collar 3, and in particular, the septum 4 is firmly pressedagainst the transversal wall 22.

In the next step, the user removes the shell 51 by pulling it in theproximal direction as indicated by the arrow on FIG. 2B. The rigid shell51 comprises sloped surfaces 53 which are in abutment against the radialprojections 45. When the user pulls on the rigid shell 51 in theproximal direction, the sloped surfaces become coupled to the radialprojections 45. As a consequence, since the pulling member 40 is safelyattached to the pierceable elastomeric piece 30, the elastomeric piece30 becomes coupled to the sloped surfaces 53 via the radial projectionsof the pulling member 40, and both the pulling member 40 and thepierceable elastomeric piece 30 are drawn in the proximal direction (notshown). Once each radial projection 45 reaches the recess 24 e of window24, it becomes engaged therein, and the proximal movement of the pullingmember 40 and pierceable elastomeric piece 30 is stopped, while thesloped surfaces 53 are disengaged from the radial projections 45 as theuser continues fully removing the rigid shell 51.

The pierceable elastomeric piece 30 thus reaches its second position, asshown in FIGS. 6A-B, proximally spaced from its first position withrespect to the tubular body 20, in which the distal plug 34 releases theseal of the central hole 23.

Because of the outer surface 4 a of the septum 4 being in tight contactwith the distal surface of the transversal wall 22, while the usercauses the pierceable elastomeric piece to transition from its firstposition to its second position, the outer surface 4 a of the septum 4replaces the distal plug 34 of the pierceable elastomeric piece 30 inits function of sealing the central hole 23 of the transversal wall 22:as a consequence, when the pierceable elastomeric piece 30 is moved fromits first position to its second position, a vacuum is created in theinner cavity 60 and air from the outside automatically enters the innercavity 60 via the air inlet 80 formed by the combination of the window24, the tubular space 70 and the labyrinthic path 37. The air from theoutside is caused to travel through the labyrinthic path 70, saidlabyrinthic path 70 forming a filtering system for decontaminating air:as a consequence, when the air from the outside reaches the inner cavity60, said air is decontaminated.

Therefore, in the second position of the pierceable elastomeric piece 30as shown on FIGS. 6A-B, the inner cavity 60 is filled withdecontaminated air. Since this inner cavity 60 is located between thepierceable elastomeric piece 30 of the adaptor 10 and the outer surface4 a of the septum 4 of the vial 1, introducing the needle 5 of aninjection device 100 to be filled with a dose of the product containedin the vial 1 in the vial as shown in FIGS. 6A-B demonstrates that theneedle 5 pierces and traverses the elastomeric piece 30 of the adaptor10 in the first place. During this step, the needle 5 mechanically rubsagainst the material forming the elastomeric piece 30 and it isnaturally cleaned, as the potential bacteria are wiped out from theneedle 5 when said needle 5 penetrates the elastomeric piece 30. Inaddition, once the needle 5 protrudes out of the elastomeric piece 30 ofthe adaptor 10 via the distal plug 34, it enters the inner cavity 60,which is filled with decontaminated air. The needle 5 is therefore notcontaminated and it can further enter the septum 4 of the vial 1 with norisk to be contaminated by any foreign elements.

The user may repeat the piercing step with the needle 5 of a new emptyinjection device 100 until all the doses contained in the vial 1 areremoved. Indeed, each time a dose of product is removed from the vial 1,the vacuum thereby created in the vial 1 is transferred to the innercavity 60 via the hole generated in the septum 4 by the needle 5. Theinner cavity 60 consequently draws additional air from the outside.Since this additional air needs to go through the filtering systemformed by the labyrinthic path 37 of the air inlet 80 before reachingthe inner cavity 60, the inner cavity 60 remains filled withdecontaminated air during the whole process of removing successivelyseveral doses of product from the vial 1. By avoiding all directcontamination via a needle and all indirect contamination from theoutside air, the adaptor 10 of the invention acts as a protection of theseptum 4 during the lifetime of the vial 1.

During the whole process of removing one or more doses of product fromthe vial 1, the pierceable elastomeric piece 30 is maintained in itssecond position by means of radial projections 45 being engaged in therecess 24 e of window 24. The radial projections 45 and the recess 24 etherefore form a locking system for maintaining the pierceableelastomeric piece 30 in its second position. Due to this locking systemthe adaptor 10, once secured on the collar 3 of the vial 1, constitutesa protection against misuse of the product stored in the vial 1. Asecured adaptor can thus serve as a proof of sterility of the drug orvaccine stored inside the vial 1.

FIGS. 7-12B show other embodiments of the adaptor 10 of FIGS. 2A-6B. Thereferences designating the same elements as in FIGS. 2A-6B have beenmaintained on FIGS. 7-12B.

With reference to FIG. 7 is shown the adaptor 10 of FIGS. 2A-6B forwhich the inner wall of the inner cavity 60 is provided with aanti-condensation coating 90. When a medical container, such as a vial1, is moved from a refrigerated storage area to an external environment,the difference of temperature may yield condensation, particularly inhumid areas. The condensation is a favorable environment for bacteriadevelopment and it may form on the surface of the inner cavity 60. Usingan anti-condensation coating allows avoiding contamination, even in thecase where a bacteria reaches the inner cavity. As a result, neither theneedle 5 of the injection device nor the product stored in the vial 1are contaminated.

With reference to FIG. 8 is shown the adaptor 10 of FIGS. 2A-6B furthercomprising a pierceable decontamination insert 91 located proximallywith respect to the pierceable elastomeric piece 30. On the embodimentshown, the decontamination insert 91 comprises a sterilizing gel 92. Forproceeding to the withdrawal of a dose of product from the vial 1, theneedle 5 first goes through the sterilizing gel 92, in which it issterilized, then through the elastomeric piece 30, in which it issubmitted to a mechanical cleaning, then in the inner cavity 60 filledwith decontaminated air before it contacts the septum 4. The piercing istherefore completed in improved hygienic conditions, as onlydecontaminated air may be introduced inside the vial 1.

FIGS. 9-12B show embodiments of the adaptor 10 of the invention furthercomprising a cleaning pad.

The cleaning pad may be any pad, such as fabric or sponge, for exampleout of cotton or any other porous material, and may be imbibed with acleaning solution or disinfecting composition. For example, the cleaningpad 60 may comprise a disinfecting agent. The disinfecting agents may beselected from alcohols, such as ethanol or isopropanol, organicsolvents, such as nitrofurane, toluene, phenol and derivatives thereof,derivatives of quinoline and acridine, salts such as sodiumhypochlorite, sodium chlorite or sodium chlorate, chlorine dioxide,salts of iodine, mercury, silver, ammonium, or the like or a combinationthereof. For example, the disinfecting agent may be selected accordingto the most common bacteria and viruses that may be found in the area ofuse of the vial.

In the embodiment as shown on FIG. 9, the cleaning pad 93 is provided inthe blister 50, for example lying on the inner surface of the pelliclefilm 52, and the user may use the cleaning pad 93 after having removedthe pellicle film 52, for cleaning manually the outer surface 4 a of theseptum 4 before mounting the adaptor 10 and shell 51 on the vial 1.

In embodiments, such as shown on FIGS. 10-11, the cleaning pad isconfigured so as to at least partially slide on the outer surface 4 a ofthe septum 4 during the step in which the adaptor 10 is being mounted onthe vial 1 to be secured thereon.

With reference to FIG. 11, the gripping member is a lateral clippingmember capable of being laterally mounted on the collar 3 of the vial 1under the form of a U-shaped element 126 intended to be engaged on thecollar 3 via the open part 127 of the U, along the direction indicatedby the arrow of FIG. 11, the curved part of the U partially surroundingthe collar 3, the U-shaped element 126 extending from the transversalwall 22 in the distal direction. The blister 50 is adapted to the shapeof the U-shaped element 126 and the pellicle film (already removed onFIG. 11) also faces the open part 127 of the U-shaped element 126. Asappears from FIG. 11, a cleaning pad 94 is provided on the rigid shell51, facing the open part 127 of the U-shaped element 126.

Once the user has removed the pellicle film in order to open the blister50, he approaches the adaptor 10 with the shell 50 towards the Collar 3of vial 1 (not shown), in order to mount laterally the adaptor 10 ontothe collar 3 of the vial 1. The cleaning pad 94 enters first in contactwith an edge of the outer surface 4 a of the septum 4. While the usercontinues to move laterally the adaptor 10, and thus the U-shapedelement 126 towards the collar 3 so as to mount it thereon, the cleaningpad 94 slides on the outer surface 4 a of the septum 4, until it losescontact with said septum 4 when the U-shaped element 126 reaches itsposition where it is secured on the collar 3.

During the mounting step of the adaptor 10 on the collar 3 as describedabove, the sliding of the cleaning pad 94 onto the outer surface 4 a ofthe septum 4 has wiped out the bacteria and/or contamination elementspotentially present on said outer surface 4 a. The outer surface 4 a ofthe septum 4 is therefore decontaminated when the elastomeric piece 30of the adaptor 10 comes in contact with it.

In another embodiment shown on FIG. 10, the blister 50 is fully removedbefore mounting the adaptor 10 on the vial 1, and the cleaning pad 94 isprovided on distal face of a projection 22 b of the transversal wall 22,said projection 22 b extending radially in the direction of the freeends of the U of the U-shaped element 126. The cleaning step of theouter surface 4 a of the septum 4 of embodiment of FIG. 10 is completedin the same way as described for embodiment of FIG. 11.

With reference to FIGS. 12A and 12B is shown schematically anotherembodiment of the adaptor 10 of the invention of FIGS. 2A-6B, with theskirt 26 as axial clipping member of the adaptor 10. In this embodiment,as shown on FIG. 12A, the cleaning pad is a breakable membrane 95attached to the inner wall of the distal end of the skirt 26.

As such, when the user approaches the distal free end of the skirt 26towards the collar 3 of the vial 1, the breakable membrane 95 enters incontact with the outer surface 4 a of the septum 4. While the usercontinues to move the skirt 26 distally so as to mount the adaptor 10 onthe collar 3 of the vial 1, the breakable membrane 95, which is attachedto the inner wall of the skirt 26, becomes stretched out on the outersurface 4 a of the septum 4 and finally breaks on said outer surface 4a. The membrane 95 is torn in several parts (95 a, 95 b) that slide onthe outer surface 4 a while the skirt 26 reaches its position where itis secured on the collar 3. In this position, as shown on FIG. 12B,because it is now torn in several parts (95 a, 95 b) hanging down fromthe inner walls of the skirt 26, the membrane 95 does not face theseptum 4 anymore and it does not prevent the piercing of the septum 4 bythe needle of an injection device (not shown). During the mounting stepof the adaptor 10 on the collar 3 as described above, the sliding of theseveral torn parts (95 a, 95 b) of the breakable membrane 95 on theouter surface 4 a of the septum 4 has wiped out the bacteria and/orcontamination elements potentially present on said outer surface 4 a.The outer surface 4 a of the septum 4 is therefore decontaminated whenthe distal plug 34 of the elastomeric piece 30 of the adaptor 10 comesin contact with it, as shown on FIG. 12B.

Additionally, in all the previous described embodiments of the presentinvention, the adaptor 10 can be provided with a time monitoring system(not shown). Indeed, and according to current health policies, thecontent of the vial 1 is usually considered as unsafe for injectionafter a limited period of time, for example until 28 to 30 days, even ifan adaptor 10 according to the present invention is mounted of the vial1. Therefore, a time monitoring system can be added to the adaptoraccording to the invention in order to monitor the elapsing time fromthe first dose withdrawing or to indicate to the user what is the timeremaining before the 28 or 30 days deadline.

This time monitoring system could be an electronic timer or a systembased on the diffusion of ink into a circuit. For example, the elapsingor remaining time can be monitored by the kinetic of ink progression ina microfluidic circuit. Such systems are particularly attractive becausethey are small and reliable. For example, such a system could beintegrated onto the outside surface of the tubular body 20, for exampleon the tubular element 21 or on the transversal wall 22. Such systemsare commercially available under the trademark Timestrip®.

Furthermore, the time monitoring system could be triggered eithermanually by the user or automatically. An automatic trigger could occurwhen the adaptor 10 is mounted on the collar 3 of the vial 1, whichassumes a first dose withdrawing shortly afterwards. For example, suchtime monitoring label, placed on an adaptor 10 could be triggered by anadditional peg (not shown) placed into the blister 50 that comes incontact with the time monitoring system and therefore activates it whenthe user applies a distal pressure on the top of the shell 51.

Such a time monitoring system is valuable to prevent the injection ofpotentially expired vaccines or drugs to patients. Moreover, it alsofacilitates the supply chain or stock management in drugstores andavoids wastage of valuable drugs and vaccines by encouraging the use ofthe first opened vials.

The adaptor of the invention allows for the repeated withdrawal of dosesof product contained in a multidose vial in favorable hygienicconditions.

The invention claimed is:
 1. An adaptor for coupling with a medicalcontainer having a collar closed by a septum, said septum having anouter surface directed towards an outside of the medical container, theadaptor comprising: a tubular body substantially closed at a distal endwith a transversal wall provided with a central hole and substantiallyclosed at a proximal end by a pierceable elastomeric piece, saidpierceable elastomeric piece defining a distal plug at a distal endthereof, said pierceable elastomeric piece, transversal wall and tubularbody together defining an inner cavity of said adaptor, said pierceableelastomeric piece being movable within said tubular body between a firstposition, in which said distal plug is seated within and forms a sealwith said central hole, and a second position, in which the distal plugis proximally spaced from said first position, in which said distal plugis displaced from said central hole, an air inlet for allowing air fromthe outside to enter said inner cavity at least when said pierceableelastomeric piece moves from the first position to the second position,said air inlet comprising a filtering system for decontaminating saidentering air before it reaches said inner cavity, and a gripping memberfor securing the adaptor to the medical container, so that a distalsurface of said transversal wall is brought in contact with the outersurface of said septum when said adaptor is secured on said medicalcontainer.
 2. The adaptor of claim 1, further comprising a pullingmember, safely attached to said pierceable elastomeric piece, forallowing a user to manually move said pierceable elastomeric piece fromthe first position to the second position.
 3. The adaptor of claim 1,further comprising a locking system for maintaining said pierceableelastomeric piece in the second position.
 4. The adaptor claim 1 furthercomprising a blister surrounding said adaptor in a storage state.
 5. Theadaptor of claim 4, wherein the blister is removable by proximal forceexerted on the blister, the blister comprises a coupling surface forreleasably coupling the blister to the pierceable elastomeric pieceduring the step of removal of the blister, removal of said blisterthereby causing the pierceable elastomeric piece to transition from thefirst position to the second position.
 6. The adaptor of claim 1,wherein the gripping member is a lateral clipping member capable ofbeing laterally mounted on the collar of said medical container.
 7. Theadaptor of claim 6, wherein said lateral clipping member comprises aU-shaped element intended to be engaged on said collar via the open partof the U-shaped element, the curved part of the U-shaped elementpartially surrounding the collar, said U-shaped element extending fromsaid transversal wall in a distal direction.
 8. The adaptor of claim 1,wherein the gripping member is an axial clipping member capable of beingaxially mounted on the collar of said medical container.
 9. The adaptorof claim 8, wherein the axial clipping member comprises a skirt capableof being axially engaged on said collar, said skirt extending from saidtransversal wall in a distal direction.
 10. The adaptor of claim 1,further comprising a cleaning pad, said cleaning pad being configured toat least partially slide on said outer surface of said septum when theadaptor is being mounted on the medical container.
 11. The adaptor ofclaim 6, further comprising a cleaning pad, said cleaning pad beingconfigured to at least partially slide on said outer surface of saidseptum when the adaptor is being mounted on the medical container,wherein said lateral clipping member comprises a U-shaped elementintended to be engaged on said collar via the open part of the U-shapedelement, the curved part of the U-shaped element partially surroundingthe collar, said U-shaped element extending from said transversal wallin a distal direction and said transversal wall is provided with aprojection extending radially in a direction of the free ends of the U,a distal face of said projection being provided with said cleaning pad.12. The adaptor of claim 8, further comprising a cleaning pad, saidcleaning pad being configured to at least partially slide on said outersurface of said septum when the adaptor is being mounted on the medicalcontainer, wherein the axial clipping member comprises a skirt capableof being axially engaged on said collar, said skirt extending from saidtransversal wall in a distal direction and the cleaning pad is abreakable membrane attached to an inner wall of said skirt.
 13. Theadaptor of claim 10, wherein said cleaning pad is located on a removablepart of said adaptor.
 14. The adaptor of claim 1, further comprising apierceable decontamination insert located proximally with respect tosaid pierceable elastomeric piece.
 15. The adaptor of claim 1, whereinthe pierceable elastomeric piece is self-resealing.
 16. The adaptor ofclaim 1, wherein the pierceable elastomeric piece is made of a materialselected from synthetic polyisoprene, natural rubber, silicone rubber,thermoplastic elastomers and combinations thereof.
 17. The adaptor ofclaim 10, wherein the cleaning pad comprises a disinfecting agent. 18.The adaptor of claim 1, wherein an inner wall of the inner cavity iscoated with an anti-condensation coating.
 19. An assembly comprising amedical container having a collar closed by a septum, said septum havingan outer surface directed towards an outside of the medical container,and an adaptor according to claim
 1. 20. An adaptor for coupling with amedical container having a collar closed by a septum, said septum havingan outer surface directed towards an outside of the medical container,the adaptor comprising: a tubular body substantially closed at a distalend with a transversal wall provided with a central hole andsubstantially closed at a proximal end by a pierceable elastomericpiece, said pierceable elastomeric piece, transversal wall, and tubularbody together defining an inner cavity of said adaptor, said pierceableelastomeric piece being movable within said tubular body between a firstposition, in which a distal part of said pierceable elastomeric pieceforms a seal with said central hole, and a second position, in whichsaid distal part is displaced from said central hole, an air inlet forallowing air from the outside to enter said inner cavity at least whensaid pierceable elastomeric piece moves from the first position to thesecond position, said air inlet comprising a filtering system fordecontaminating said entering air before it reaches said inner cavityand said air inlet being in fluid communication with said central holewhen said pierceable elastomeric piece is in said second position, and agripping member for securing the adaptor to the medical container, sothat a distal surface of said transversal wall is brought in contactwith the outer surface of said septum when said adaptor is secured onsaid medical container.